Incidence and impact of anticoagulation-associated abnormal menstrual bleeding in women after venous thromboembolism

Abstract

Preliminary data and clinical experience have suggested an increased risk of abnormal uterine bleeding (AUB) in women of reproductive age treated with anticoagulants, but solid data are lacking. The TEAM-VTE study was an international, multicentre, prospective cohort study in women aged 18-50 diagnosed with acute venous thromboembolism (VTE). Menstrual blood loss was measured by Pictorial Blood Loss Assessment Charts (PBAC) at baseline for the last menstrual cycle before VTE diagnosis and prospectively for each cycle during three-six month follow-up. AUB was defined as an elevated PBAC score (>100 or >150) or self-reported AUB. AUB-related quality of life (QoL) was assessed at baseline and end of follow-up using the Menstrual Bleeding Questionnaire (MBQ). The study was terminated early because of slow recruitment due to the pandemic. Of the 98 women, 65 (66%) met at least one of the three definitions of AUB during follow-up (95% confidence interval (CI) 57-75%). AUB occurred in 60% (36/60) of women without AUB before VTE diagnosis ('new-onset' AUB; 95%CI 47-71%). Overall, QoL decreased over time with a mean MBQ increase of 5.1 points (95%CI 2.2-7.9), but this decrease in QoL was only observed among women with new-onset AUB. To conclude, two out of three women who start anticoagulation for acute VTE suffer from AUB, with a considerable negative impact on QoL. These findings should be a call to action to increase awareness and provide evidence-based strategies for preventing and treating AUB in this setting. This was an academic study (NCT04748393 at www.clinicaltrials.gov); no funding was received.

How do anticoagulants impact menstrual bleeding and quality of life? - The PERIOD study

“…Our findings support the results of the recently published TEAM VTE study, which is the only other study, to the best of our knowledge, which has attempted to objectively assess this issue in anticoagulated women during the DOAC era [ 29 ]. The TEAM VTE study recruited 98 newly diagnosed VTE patients, asking them to complete a PBAC and the MBQ, over 3 to 6 months follow-up.…”

Real‐world experience of direct oral anticoagulant use in a single pediatric center

“…HMB continues to be an important safety measure and should continue to be investigated in adolescent females. Previous adult data have noted that HMB can be seen in up to 75% of women on DOACs, and symptoms may differ across different anticoagulants and even different DOACs 29–31 . Rivaroxaban was noted to have a two‐fold increase in abnormal uterine bleeding compared to warfarin, but this increased risk was not seen with either edoxaban or apixaban 29 .…”

“…Previous adult data have noted that HMB can be seen in up to 75% of women on DOACs, and symptoms may differ across different anticoagulants and even different DOACs. [29][30][31] Rivaroxaban was noted to have a two-fold increase in abnormal uterine bleeding compared to warfarin, but this increased risk was not seen with either edoxaban or apixaban. 29 Specifically for pediatrics, the EINSTEIN-Jr phase 2 trial noted 15% of adolescent females reported menorrhagia, and in the phase 3 trial up to 19% of patients on rivaroxaban noted HMB compared to 7% of adolescent females on standard anticoagulation.…”

Editorial: Venous thromboembolism and pregnancy

“…Thromboprophylaxis aims to protect patients from venous thromboembolism, but at the risk of an increased risk of bleeding, which may occur in different manners during pregnancy and post-partum (5). During the post-partum, the use of direct oral anticoagulants may also be challenging, as it is associated with an increased risk of genitourinary bleeding ( 6), a setting that may need dedicated assessment tools (7). In these situations, the potential of anti-Factor XI (8) deserves specific consideration.…”